Clinical Efficacy and Mechanism of tDCS for Dysphagia in PD

NCT07153692 | Recruiting DMC

• 1 other identifier: （2024）lunshenyan（1309）
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to verify transcranial direct current stimulation(tDCS) efficacy for Parkinson's disease (PD)-related dysphagia and its mechanism. Subjects are randomly split into two groups: control (sham tDCS + conventional dysphagia treatment) and experimental (real tDCS + conventional treatment). Assessments will be conducted at baseline, after the completion of intervention, and at the 3-month follow-up. Swallowing function will be evaluated via gold-standard videofluoroscopic swallowing study (VFSS) and scales. Resting-state functional magnetic resonance imaging (rs-fMRI) or functional near-infrared spectroscopy (fNIRS) will be measures for tracking changes in abnormal brain regions/networks. Correlations between swallowing recovery and brain function changes, plus group imaging differences, will reveal tDCS's neurophysiological mechanism.

Conditions

Parkinson's Disease and Parkinsonism; Dysphagia

Keywords

Parkinson's disease; Atypical Parkinsonian Syndromes; dysphagia; tDCS; VFSS

Outcome Measures

Primary Outcomes (7)

• Rosenbek Penetration-Aspiration Scale (PAS):

  Scored 1-8, with higher scores indicating poorer swallowing safety. 1. Level 1: The bolus does not enter the airway; it remains entirely within the oral cavity or pharynx and is propelled normally. 2. Level 2: The bolus enters the supraglottic area (e.g., vallecula) but does not touch the vocal cords, and is completely cleared (e.g., via swallowing or coughing). 3. Level 3: The bolus enters the supraglottic area without touching the vocal cords, but residue remains (not fully cleared). 4. Level 4: The bolus touches the vocal cords but does not enter the subglottic airway, and is completely cleared. 5. Level 5: The bolus touches the vocal cords without entering the subglottic airway, but residue remains. 6. Level 6: The bolus enters the subglottic airway (into the trachea) but is completely cleared by the patient (e.g., via coughing). 7. Level 7: The bolus enters the subglottic airway; the patient exhibits protective responses (e.g., coughing) but cannot fully clear it, leaving

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• Videofluoroscopic Dysphagia Scale (VDS)

  14 items in total, including 7 items for oral-phase swallowing function and 7 for pharyngeal-phase function, used to assess overall swallowing function;

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• oral residue

  Post-swallow residue was scored 0-3, with higher scores indicating more food residue and lower swallowing efficiency

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• Amplitude of Low Frequency Fluctuation (ALFF)

  ALFF focuses on the low-frequency components of these HbO/HbR time series. It is defined as the average amplitude of hemodynamic signal fluctuations within a specific low-frequency range (typically 0.01-0.1 Hz, though the exact band may vary by study). This range is chosen because it captures slow, spontaneous oscillations in cerebral blood flow and oxygenation, which are hypothesized to reflect synchronized neural activity across brain regions (e.g., default mode network, sensorimotor networks). Mathematically, ALFF quantifies the "strength" of these low-frequency oscillations: a higher ALFF value indicates more prominent or intense fluctuations in the target frequency band, suggesting greater spontaneous hemodynamic (and thus neural) activity in that brain region.

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• Functional Connectivity (FC)

  Functional Connectivity (FC) refers to the statistical association or synchronization between spontaneous hemodynamic signals from different cortical regions, reflecting the coordinated activity of spatially distinct brain areas. It quantifies how closely the neural activity (inferred from blood oxygenation changes) in one brain region correlates with that in another, providing insights into the integration of brain networks.

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• vellaculae residue

  The residue amount was rated on a scale from 0 to 3: 0 indicates that no residue was visible, 1 indicates mild residue(the level of contrasted material constituted less than 25% of the height of the structure), 2 indicates moderate residue (the level of contrasted material constituted between 25 and 50%of the height of the structure), and 3 indicates severe residue(the level was higher than 50% of the height of the structure).

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• pyriform sinuses residue

  The residue amount was rated on a scale from 0 to 3: 0 indicates that no residue was visible, 1 indicates mild residue(the level of contrasted material constituted less than 25% of the height of the structure), 2 indicates moderate residue (the level of contrasted material constituted between 25 and 50%of the height of the structure), and 3 indicates severe residue(the level was higher than 50% of the height of the structure).

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

Secondary Outcomes (4)

• temporal indicators

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• spatial indicators

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• Swallowing Disorder Questionnaire (SDQ)

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• Functional Oral Intake Scale (FOIS)

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

Other Outcomes (3)

• Unified Parkinson's Disease Rating Scale-III (UPDRS-III)

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• Swallowing Quality of Life Questionnaire (SWAL-QOL)

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

• Non-Motor Symptoms Scale (NMSS) for Parkinson's Disease

  at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

Study Arms (2)

real tDCS group

EXPERIMENTAL

tDCS Treatment Protocol The anode of the electrode pad will be placed on the swallowing sensorimotor cortex (S1/M1). The cathode will be placed on the contralateral supraorbital margin. The S1/M1 areas of the left and right hemispheres will be stimulated alternately, with a current intensity of 1.6mA. The treatment will be given once daily, 20 minutes per session, 5 times a week, for 2 consecutive weeks, totaling 10 sessions (5 sessions for each hemisphere). Conventional Dysphagia Treatment 1. Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.; 2. Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;

Device: tDCS; Behavioral: Conventional Dysphagia Treatment

sham tDCS group

SHAM COMPARATOR

Sham tDCS Treatment Protocol The electrode positions and treatment frequency of sham tDCS will be the same as those of real tDCS. The current is 0.05 mA. The treatment will be given once daily, 20 minutes per session, 5 times a week, for 2 consecutive weeks, totaling 10 sessions (5 sessions for each hemisphere). Conventional Dysphagia Treatment 1. Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.; 2. Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;

Behavioral: Conventional Dysphagia Treatment; Device: sham tDCS

Interventions

tDCS DEVICE

The IS200 intelligent electrical stimulator, manufactured in Chengdu, Sichuan, will be used. The electrode pads are 4cm × 6cm in size. The anode of the electrode pad will be placed on the swallowing sensorimotor cortex (S1/M1). The specific positioning will follow the international 10-20 electroencephalographic system: the left S1/M1 area is located at the midpoint of the line connecting C3 and T3 in the left hemisphere; the right S1/M1 area is located at the midpoint of the line connecting C4 and T4 in the right hemisphere. The cathode will be placed on the contralateral supraorbital margin. The S1/M1 areas of the left and right hemispheres will be stimulated alternately, with a current intensity of 1.6mA. The treatment will be given once daily, 20 minutes per session, 5 times a week, for 2 consecutive weeks, totaling 10 sessions (5 sessions for each hemisphere).

real tDCS group

Conventional Dysphagia Treatment BEHAVIORAL

1. Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.; 2. Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;

real tDCS group; sham tDCS group

sham tDCS DEVICE

According to previous literature, the electrode positions and treatment frequency of sham tDCS will be the same as those of real tDCS. The current will be adjusted to 0.05mA.

sham tDCS group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the Chinese Diagnostic Criteria for Parkinson's Disease (2016) or MDS Diagnostic Criteria for Multiple System Atrophy or Progressive Supranuclear Palsy;
• VFSS examination indicates dysphagia;
• Mini-Mental State Examination (MMSE) score \>23;
• Willing to cooperate with the study and sign the informed consent form;

You may not qualify if:

• Comorbid with other diseases that cause dysphagia;
• Comorbid with pneumonia, or severe cardiac/renal insufficiency;
• Having metal implants in the body
• With cognitive impairment or inability to cooperate.

Sponsors & Collaborators

• Wang Ping: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (5)

• Ding X, Gao J, Xie C, Xiong B, Wu S, Cen Z, Lou Y, Lou D, Xie F, Luo W. Prevalence and clinical correlation of dysphagia in Parkinson disease: a study on Chinese patients. Eur J Clin Nutr. 2018 Jan;72(1):82-86. doi: 10.1038/ejcn.2017.100. Epub 2017 Jul 12.

  PMID: 28699630 RESULT

• Henry KA, Singh R, Zhang N, Lyons MK, McNett K, Neal MT, Mehta SH. Effect of STN/GPi DBS on swallowing function in Parkinson's disease as assessed by Video fluoroscopy: A retrospective study. Parkinsonism Relat Disord. 2022 Oct;103:136-140. doi: 10.1016/j.parkreldis.2022.08.017. Epub 2022 Sep 11.

  PMID: 36115199 RESULT

• Wang P, Wang B, Chen X, Xiong B, Xie F, Wu S, Tang Y, Chen S, Ding X, Liu P, Luo W. Six-Year Follow-Up of Dysphagia in Patients with Parkinson's Disease. Dysphagia. 2022 Oct;37(5):1271-1278. doi: 10.1007/s00455-021-10387-0. Epub 2021 Nov 26.

  PMID: 34826007 RESULT

• Gandhi P, Steele CM. Effectiveness of Interventions for Dysphagia in Parkinson Disease: A Systematic Review. Am J Speech Lang Pathol. 2022 Jan 18;31(1):463-485. doi: 10.1044/2021_AJSLP-21-00145. Epub 2021 Dec 10.

  PMID: 34890260 RESULT

• Dashtelei AA, Nitsche MA, Salehinejad MA, Habibi AH, Bakhtyiari J, Khatoonabadi AR. Adjunctive transcranial direct current stimulation to improve swallowing functions in Parkinson's disease. EXCLI J. 2024 Jan 18;23:95-107. doi: 10.17179/excli2023-6496. eCollection 2024.

  PMID: 38487086 RESULT

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Deglutition Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Ping Wang

  Second Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Wang, MS

CONTACT

15158113194; wangping6288@zju.edu.cn

Bo Wang, MD

CONTACT

wangke1121@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: senior therapist

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: September 4, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)